Reolysin Combined With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Metastatic Castration Resistant Prostate Cancer

NCT01619813 | Completed Phase 2 DMC

• 1 other identifier: I209
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to find out if giving Reolysin in combination with docetaxel and prednisone can offer better results than standard therapy with docetaxel and prednisone.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Progression

  Efficacy will be based on the lack of disease progression measured at 12 weeks.

  12 weeks

Secondary Outcomes (6)

• Effect of Docetaxel and Reolysin on circulating tumour cells

  12 weeks

• PSA change rate

  24 months

• Objective Response

  24 months

• Overall Survival

  24 months

• Determine patient tolerability and toxicity of Reolysin and Docetaxel in combination

  24 months

Study Arms (2)

Docetaxel, Reolysin and Prednisone

ACTIVE COMPARATOR

Drug: Docetaxel, Reolysin and Prednisone

Docetaxel and Prednisone

ACTIVE COMPARATOR

Drug: Docetaxel and Prednisone

Interventions

Docetaxel, Reolysin and Prednisone DRUG

Docetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly beginning on day 1, cycle 1. Reolysin will be delivered as a 1-hour infusion days 1-5. On day 1 of each cycle, when both agents are given, the docetaxel will be given first. Prednisone 5 mg BID will be given beginning day 1. Each cycle is 3 weeks in length.

Docetaxel, Reolysin and Prednisone

Docetaxel and Prednisone DRUG

Docetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly. Prednisone 5mg BID will be given beginning Day 1. Each cycle is 3 weeks in length.

Docetaxel and Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histological diagnosis of adenocarcinoma of the prostate.
• All patients must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) available for translational studies.
• Presence of clinically and/or radiologically documented disease (measurable or non-measurable). All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative). Patients with elevated PSA only are not eligible.
• Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (\< 1.7 nmol/L) must be present.
• Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated due to progression following castration.
• Progression is defined as one or both of the following:
• PSA Progression:
• A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of ≥2 ng/ml and must be performed no longer than 7 days prior to trial randomization. Patients who have had prolonged responses to combined androgen blockade should be evaluated for a withdrawal response prior to confirming eligibility OR
• Radiological Progression:
• defined as the development of new metastatic lesions or progression in target disease (RECIST 1.1) with a stable or rising PSA.
• The PSA must be ≥ 5 ng/ml at the time of study entry.
• ECOG performance of 0, 1 or 2.
• Age ≥ 18 years of age.
• Patients must have a life expectancy of ≥ 12 weeks.
• Previous Therapy

You may not qualify if:

• Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumours curatively treated with no evidence of disease for ≥ 3 years.(Please call NCIC CTG if any questions about the interpretation of this criterion).
• Patients who are on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
• Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
• Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components.
• Patients with history of central nervous system metastases or untreated spinal cord compression.
• Patients who have had prior treatment with docetaxel for advanced/metastatic disease.
• Men who are not sterile unless they use an adequate method of birth control.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Oncolytics Biotech: collaborator

Study Sites (11)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Abbotsford Centre

Abbotsford, British Columbia, V2S 0C2, Canada

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• Eigl BJ, Chi K, Tu D, Hotte SJ, Winquist E, Booth CM, Canil C, Potvin K, Gregg R, North S, Zulfiqar M, Ellard S, Ruether JD, Le L, Kakumanu AS, Salim M, Allan AL, Feilotter H, Theis A, Seymour L. A randomized phase II study of pelareorep and docetaxel or docetaxel alone in men with metastatic castration resistant prostate cancer: CCTG study IND 209. Oncotarget. 2018 Jan 17;9(8):8155-8164. doi: 10.18632/oncotarget.24263. eCollection 2018 Jan 30.

  PMID: 29487723 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; reolysin; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bernhard Eigl

  BCCA Vancouver

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: December 14, 2012
• Primary Completion: April 26, 2016
• Study Completion: May 20, 2016
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)